The Manufacturing Engineer is responsible for performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment. These activities include collaboratively identifying/implementing process improvements, writing/executing validation protocols, summarizing results into reports, and supporting all production activities as needed. Assist in troubleshooting, equipment/facility design, and cost improvement projects utilizing project management, Six Sigma, or other skills.
Essential Duties:
- Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing processes to manufacture and package multiple types of nasal spray drug products
- Assist in the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports
- Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements
- Assist in labeling and packaging development and testing
- Work on multiple process development and validation projects simultaneously and coordinate test work with various other departments
- Participate in the development and implementation of procedural or automation improvement changes
- Write procedures, protocols and reports for manufacturing, utility, lab equipment, cleaning and process validation
- Compile validation packages and assure all required documentation is accurate and complete
- Champion process improvement projects and ensure equipment and systems remain in a qualified state
- Assist or conduct investigations to resolve deviations, including Root Cause Analysis (RCA)
- Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
- Point person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols
- Initiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules
- Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPAs through participation on cross functional teams
- Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, and support of out-of-tolerance investigations related to instrument calibrations
- Lead risk assessment exercises related to equipment and processes, including Failure Mode Effect Analysis (FMEA).
- Train technicians on Production Batch Records
- Other duties as assigned
